Corinne Miceli-Richard1,2, Maxime Dougados3,4,5, Omar Al Tabaa3, Adrien Etcheto3, Sophie Dumas6, Frederic Batteux7,8, Claire Goulvestre7, Anna Moltó3,4. 1. Department of Rheumatology - Hôpital Cochin. Assistance Publique - Hôpitaux de Paris, EULAR center of excellence, Paris Descartes University, Paris University, 27 rue du Faubourg Saint-Jacques, 75014, Paris, France. corinne.miceli@aphp.fr. 2. Immunoregulation Unit, Unité Mixte AP-HP/Institut Pasteur, Institut Pasteur, Paris, France. corinne.miceli@aphp.fr. 3. Department of Rheumatology - Hôpital Cochin. Assistance Publique - Hôpitaux de Paris, EULAR center of excellence, Paris Descartes University, Paris University, 27 rue du Faubourg Saint-Jacques, 75014, Paris, France. 4. INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris, France. 5. Immunoregulation Unit, Unité Mixte AP-HP/Institut Pasteur, Institut Pasteur, Paris, France. 6. Department of Pharmacy, Cochin Hospital, AP-HP, Paris, France. 7. Department of Immunology, Cochin Hospital, AP-HP, Paris, France. 8. Sorbonne Paris-Cité, INSERM U1016, Cochin Institute, CARPEM, Paris Descartes University, Paris University, Paris, France.
Abstract
OBJECTIVES: To describe the switch to biosimilar etanercept (bETN), evaluate factors associated with this switch, and evaluate the efficacy of this switch in a real-life setting METHODS: We included patients, from October 2016 to April 2017, with rheumatoid arthritis (RA) and spondyloarthritis (SpA) who received innovator ETN (iETN) for at least 6 months. After receiving information on biosimilars, all physicians were invited to propose a switch from iETN to bETN. Factors associated with bETN discontinuation were explored by univariate and multivariate analyses. We estimated the proportion of patients still on bETN over time by Kaplan-Meier survival analysis. We assessed serum trough concentrations of iETN and bETN and anti-drug antibodies to ETN. RESULTS: Overall, 183 outpatients were eligible for a potential switch; 94 (51.6%) switched from iETN to bETN. The probability of a switch was greater with an older than younger aged physician (mean [SD] age 50.4 [14.3] with a switch vs 44.8 [11.3] with no switch, p = 0.005) and the physician having a full-time academic position than other position (56.4% with a switch vs 13.5% with no switch, p < 0.001). After a 6-month follow-up, bETN retention rate was 83% (95% CI: 0.76-0.92). The first cause of bETN discontinuation was inefficacy (50%). On multivariate analysis, no factor was independently associated with a bETN switch or discontinuation. Drug trough levels did not significantly differ by discontinuation or continuation of bETN. No patient showed anti-drug antibodies. CONCLUSION: The probability of switching from iETN to bETN was likely related to physician characteristics.
OBJECTIVES: To describe the switch to biosimilar etanercept (bETN), evaluate factors associated with this switch, and evaluate the efficacy of this switch in a real-life setting METHODS: We included patients, from October 2016 to April 2017, with rheumatoid arthritis (RA) and spondyloarthritis (SpA) who received innovator ETN (iETN) for at least 6 months. After receiving information on biosimilars, all physicians were invited to propose a switch from iETN to bETN. Factors associated with bETN discontinuation were explored by univariate and multivariate analyses. We estimated the proportion of patients still on bETN over time by Kaplan-Meier survival analysis. We assessed serum trough concentrations of iETN and bETN and anti-drug antibodies to ETN. RESULTS: Overall, 183 outpatients were eligible for a potential switch; 94 (51.6%) switched from iETN to bETN. The probability of a switch was greater with an older than younger aged physician (mean [SD] age 50.4 [14.3] with a switch vs 44.8 [11.3] with no switch, p = 0.005) and the physician having a full-time academic position than other position (56.4% with a switch vs 13.5% with no switch, p < 0.001). After a 6-month follow-up, bETN retention rate was 83% (95% CI: 0.76-0.92). The first cause of bETN discontinuation was inefficacy (50%). On multivariate analysis, no factor was independently associated with a bETN switch or discontinuation. Drug trough levels did not significantly differ by discontinuation or continuation of bETN. No patient showed anti-drug antibodies. CONCLUSION: The probability of switching from iETN to bETN was likely related to physician characteristics.
Authors: R K Dore; S Mathews; J Schechtman; W Surbeck; D Mandel; A Patel; L Zhou; P Peloso Journal: Clin Exp Rheumatol Date: 2007 Jan-Feb Impact factor: 4.473